Trial Outcomes & Findings for The SUCCEED Trial of Secondary Stroke Prevention (NCT NCT01763203)

NCT ID: NCT01763203

Last Updated: 2019-11-26

Results Overview

Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 487 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-11-26

Participant Flow

The dates of the recruitment period are from February 13, 2014 through August 31, 2017.

Not applicable; all enrolled participants were assigned to an arm.

Participant milestones

Measure	Care Management+Community Health Worker Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Overall Study STARTED	241	246
Overall Study COMPLETED	208	204
Overall Study NOT COMPLETED	33	42

Reasons for withdrawal

Measure	Care Management+Community Health Worker Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Overall Study Death	4	7
Overall Study Lost to Follow-up	12	12
Overall Study Withdrawal by Subject	8	12
Overall Study Moved out of study region	7	10
Overall Study Physician Decision	2	1

Baseline Characteristics

The SUCCEED Trial of Secondary Stroke Prevention

Baseline characteristics by cohort

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.	Total n=487 Participants Total of all reporting groups
Age, Continuous	57.2 years STANDARD_DEVIATION 9.0 • n=5 Participants	57.0 years STANDARD_DEVIATION 8.7 • n=7 Participants	57.1 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	92 Participants n=7 Participants	170 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants	154 Participants n=7 Participants	317 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	170 Participants n=5 Participants	177 Participants n=7 Participants	347 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	71 Participants n=5 Participants	69 Participants n=7 Participants	140 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	45 Participants n=5 Participants	42 Participants n=7 Participants	87 Participants n=5 Participants
Race (NIH/OMB) White	168 Participants n=5 Participants	167 Participants n=7 Participants	335 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	241 participants n=5 Participants	246 participants n=7 Participants	487 participants n=5 Participants
Index vascular event Ischemic stroke	190 Participants n=5 Participants	193 Participants n=7 Participants	383 Participants n=5 Participants
Index vascular event Intracerebral hemorrhage	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Index vascular event Transient ischemic attack	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Survey language English	101 Participants n=5 Participants	106 Participants n=7 Participants	207 Participants n=5 Participants
Survey language Spanish	140 Participants n=5 Participants	140 Participants n=7 Participants	280 Participants n=5 Participants
Location of birth Born in the US	65 Participants n=5 Participants	69 Participants n=7 Participants	134 Participants n=5 Participants
Location of birth Born outside of the US	176 Participants n=5 Participants	176 Participants n=7 Participants	352 Participants n=5 Participants
Location of birth Not reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Employment status prior to vascular event Working for pay	125 Participants n=5 Participants	141 Participants n=7 Participants	266 Participants n=5 Participants
Employment status prior to vascular event Not working for pay	115 Participants n=5 Participants	102 Participants n=7 Participants	217 Participants n=5 Participants
Employment status prior to vascular event Not reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Education Bachelor's degree and higher	33 Participants n=5 Participants	22 Participants n=7 Participants	55 Participants n=5 Participants
Education Some college	29 Participants n=5 Participants	37 Participants n=7 Participants	66 Participants n=5 Participants
Education High school graduate/GED (no college)	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Education Some high school but not a high school graduate	59 Participants n=5 Participants	56 Participants n=7 Participants	115 Participants n=5 Participants
Education First to eighth grade	78 Participants n=5 Participants	82 Participants n=7 Participants	160 Participants n=5 Participants
Education No school/kindergarten only	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Education Not reported	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Systolic Blood Pressure	133.1 mm Hg Standard Deviation 20.5	136.9 mm Hg Standard Deviation 21.9

SECONDARY outcome

Timeframe: 12 months

non-HDL cholesterol will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Dyslipidemia	98.7 mg/dL Standard Deviation 47.8	104.1 mg/dL Standard Deviation 49.2

SECONDARY outcome

Timeframe: 12 months

Hemoglobin A1C will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Percentage of Glycated Hemoglobin (Hemoglobin A1C)	6.5 percentage of glycated hemoglobin Standard Deviation 1.2	6.6 percentage of glycated hemoglobin Standard Deviation 1.3

SECONDARY outcome

Timeframe: 12 months

C-reactive protein will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Inflammation: C-reactive Protein	1.1 mg/L Standard Deviation 3.2	1.2 mg/L Standard Deviation 3.2

SECONDARY outcome

Timeframe: 12 months

Body mass index will be measured at 12-months with a height and weight ratio. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Body Mass Index	29.5 kg/meter^2 Standard Deviation 5.9	29.2 kg/meter^2 Standard Deviation 5.1

SECONDARY outcome

Timeframe: 12 months

Waist circumference will be measured at 12-months according to the National Institutes of Health (NIH) guidelines. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Waist Circumference	102.9 cm Standard Deviation 14.3	101.4 cm Standard Deviation 12.5

SECONDARY outcome

Timeframe: 12 months

The International Physical Activity Questionnaire (IPAQ) Short 7-Day version will be collected as part of the 12 month outcome survey. The questionnaire will also be collected at baseline and 3 months to track changes over the entire study period. The IPAQ score reflects energy expenditure of physical activity, and is reported in units of 'met minutes' which means metabolic equivalent. The minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Physical Activity	1251 IPAQ met minutes Standard Deviation 1808	1344 IPAQ met minutes Standard Deviation 1874

SECONDARY outcome

Timeframe: 12 months

A single question, "Are you currently watching or reducing your sodium or salt intake?" from the Behavioral Risk Factor Surveillance System 2013, which has a dichotomous 'yes/no' response, will be collected as part of the 12 month outcome survey. The question will also be collected at baseline, 3 months, and at 8 months, to track changes over the entire study period

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Salt Intake unknown	33 Participants	44 Participants
Salt Intake Yes	181 Participants	168 Participants
Salt Intake No	27 Participants	34 Participants

SECONDARY outcome

Timeframe: 12 months

A single question from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The question is "During the past month, how often did you drink regular soda or pop that contains sugar?" The participant gives a number, and the frequency (per day, per week, or per month) is also recorded. The average daily servings of soda over the prior month is calculated, and the question is scored as a dichotomous variable of greater than or equal to 1 serving of soda per /day versus less than one serving of soda per day. The question will also be collected at baseline and at 3 months, to track changes over the entire study period

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Soda Intake No soda servings per day in past month	107 Participants	102 Participants
Soda Intake Any soda servings per day over past month	99 Participants	99 Participants
Soda Intake Unknown	35 Participants	45 Participants

SECONDARY outcome

Timeframe: 12 months

Two questions from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The questions are "During the past month, how many times did you eat fruit? Do not count juices" and "During the past month, how many times did you eat any other vegetables like green salad, green beans or potatoes? Do not include fried potatoes." For each question, the participant gives a number, and the frequency (per day, per week, or per month) is also recorded. Responses are converted to a number for day for each question, then summed across the two questions. The question is scored as a dichotomous variable of five or more servings of fruit and vegetables per day versus less than five servings of fruit and vegetables per day. The questions will also be collected at baseline and at 3 months, to track changes over the entire study period

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Fruit and Vegetable Intake unknown	35 Participants	46 Participants
Fruit and Vegetable Intake >= 5 fruit+vegetables servings/day in past month	22 Participants	28 Participants
Fruit and Vegetable Intake <5 fruit+vegetables servings/day in past month	184 Participants	172 Participants

SECONDARY outcome

Timeframe: 12 months

A single question from the California Health Interview Survey 2011-2012 Adult Questionnaire will be collected as part of the 12-month outcome survey. The question asks whether over the interval since the previous study interview, "were you smoking cigarettes every day, some days, or not at all?" The question will also be collected at baseline (with a time frame of over the prior year) and at 3 months, to track changes over the entire study period. The scoring for this outcome is dichotomous: "Smoking" = a response of 'every day' or 'some days', versus "Not smoking" = a response of 'not at all.'

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Smoking Smoking	25 Participants	22 Participants
Smoking Not smoking	182 Participants	181 Participants
Smoking Unknown	34 Participants	43 Participants

SECONDARY outcome

Timeframe: 12 months

An open-ended question about what the participant believes is a sign of a stroke ("What are the warning signs of a stroke? What else...what else?"), will be asked as a part of the 12 month survey. This question will also be collected at 3 months to track changes over the follow-up study period. Correct responses are numbness, weakness, difficulty speaking/understanding, vision disturbance, dizziness, and headache. Responses are scored as 0 correct, 1 correct, 2 correct, and 3 or more correct.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Knowledge About Stroke Signs 3 or more correct stroke signs	95 Participants	65 Participants
Knowledge About Stroke Signs 2 correct stroke signs	69 Participants	75 Participants
Knowledge About Stroke Signs 1 correct stroke sign	28 Participants	40 Participants
Knowledge About Stroke Signs no correct stroke sign	16 Participants	24 Participants
Knowledge About Stroke Signs unknown	33 Participants	42 Participants

SECONDARY outcome

Timeframe: 12 months

An adaptation of an existing instrument will be collected as a part of the 12 month survey. An open-ended question about what the participant believes is a stroke risk factor ("I would like to ask you about stroke risk factors, those are the things that make it more likely for somebody to have a stroke. From anything you might have heard or read, what do you believe are the risk factors associated with stroke? What else...what else?", will be asked, then converted to three dichotomous variables: correct about at least 3 stroke risk factors versus less than three; correct about at least one stroke risk factor versus none correct; and reports that blood pressure is a stroke risk factor versus does not. This question will also be collected at baseline, 3 months, and 8 months to track changes over the entire study period.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Knowledge About Stroke Risk Factors unknown	33 Participants	42 Participants
Knowledge About Stroke Risk Factors at least 3 correct stroke risk factors named	54 Participants	49 Participants
Knowledge About Stroke Risk Factors less than 3 correct stroke risk factors named	154 Participants	155 Participants

SECONDARY outcome

Timeframe: 12 months

An adaptation of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) will be collected as a part of the 12 month questionnaire. It will also be collected at baseline and 3 month to track changes over the entire study period. The CAHPS question was "Did you receive from any of your medical care providers the help you needed to make changes in your habits or lifestyle that would improve your health or prevent illness?" Response choices are: 'Yes definitely' "Yes somewhat' or 'No definitely not'.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Patient Perception of Quality of Stroke Preventative Care Yes, definitely	126 Participants	91 Participants
Patient Perception of Quality of Stroke Preventative Care Yes, somewhat	30 Participants	42 Participants
Patient Perception of Quality of Stroke Preventative Care No, definitely not	36 Participants	55 Participants
Patient Perception of Quality of Stroke Preventative Care Unknown	49 Participants	58 Participants

SECONDARY outcome

Timeframe: 12 months

Population: This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.

The Questionnaire for Verifying Stroke Free Status (QVSFS) will be collected as part of the 12 month survey. It will also be collected at baseline and 3 months to track changes over the entire study period. This questionnaire will also be collected every 6 months for up to 24 months after the study is completed to check for vascular events. The scoring was dichotomous: at least one new event (stroke, transient ischemic attack, or heart attack) versus none over the 12-month follow-up period.

Outcome measures

Measure	Care Management+Community Health Worker n=220 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=225 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Vascular Events >=one vascular event during the 12-month follow-up	26 Participants	29 Participants
Vascular Events No vascular events during the 12-month follow-up	194 Participants	196 Participants

SECONDARY outcome

Timeframe: 12 Months

A single item adapted from two questions published elsewhere will be administered at 12 months. The adapted item is "In the past week, how much of the time were you able to take your medications exactly as your doctor or nurse told you to?" Response choices are 'None of the time,' 'A little of the time,' "A good bit of the time,' 'Most of the time,' or 'All of the time.' This item will also be collected at Baseline, 3 Months, and 8 Months, to track changes over the entire study period.

Outcome measures

Measure	Care Management+Community Health Worker n=241 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=246 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Medication Adherence - Global All of the time	148 Participants	150 Participants
Medication Adherence - Global Most of the time	31 Participants	27 Participants
Medication Adherence - Global A good bit of the time	2 Participants	1 Participants
Medication Adherence - Global A little of the time	7 Participants	9 Participants
Medication Adherence - Global None of the time	7 Participants	4 Participants
Medication Adherence - Global Unknown	46 Participants	55 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.

A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for blood pressure medication, using a previously published formula. This will also be collected at 3 months, to track changes over the study period.

Outcome measures

Measure	Care Management+Community Health Worker n=161 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=161 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Medication Adherence - Blood Pressure Medication	91.6 percentage of doses Standard Deviation 24	89.4 percentage of doses Standard Deviation 27

SECONDARY outcome

Timeframe: 12 months

Population: This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.

A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for cholesterol medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.

Outcome measures

Measure	Care Management+Community Health Worker n=153 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=146 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Medication Adherence - Cholesterol Medication	86.7 percentage of doses Standard Deviation 32	87.1 percentage of doses Standard Deviation 32

SECONDARY outcome

Timeframe: 12 months

Population: This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.

A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for antithrombotic medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.

Outcome measures

Measure	Care Management+Community Health Worker n=152 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=153 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Medication Adherence - Antithrombotic Medication	88.5 percentage of doses Standard Deviation 30	89.4 percentage of doses Standard Deviation 29

SECONDARY outcome

Timeframe: 12 months

Population: Only study participants taking antidepressant medication were included in this analysis

A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for antidepressant medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.

Outcome measures

Measure	Care Management+Community Health Worker n=28 Participants Care management Care Management+Community Health Worker: Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.	Usual Care n=25 Participants Written materials Usual Care: Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
Medication Adherence - Antidepressant Medication	87.8 percentage of doses Standard Deviation 32	96.2 percentage of doses Standard Deviation 20

Adverse Events

Care Management+Community Health Worker

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Barbara Vickrey; Chair of Neurology

Icahn School of Medicine at Mount Sinai

Phone: 2122415698

Email: barbara.vickrey@mssm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place